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| Sponsored by: |
Department of Veterans Affairs |
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00018213 |
Purpose
The aim of this study is to investigate the effects of naltrexone, alone and combined with nicotine patch, on responses of smokers to smoking cues after 10 hours of tobacco deprivation. Smokers who are not seeking treatment will be assigned to one of six conditions: They will receive either 50 mg of naltrexone or a placebo pill, and also will wear a nicotine patch that has 0, 21, or 42 mg of nicotine during the tobacco deprivation period. Both the day before the medication and deprivation and at the end of 10 hours of deprivation all will be exposed to lit cigarette cues in the laboratory. Effects of the medications will be assessed on withdrawal measures, urge to smoke, psychophysiological measures, and the topography of smoking three test cigarettes. Studies such as these can help to identify potential interventions for tobacco cessation or withdrawal, and thereby could result in less suffering and mortality.
| Condition | Intervention |
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Smoking |
Drug: Naltrexone Hydrochloride Drug: Transdermal Nicotine |
| MedlinePlus related topics: | Smoking |
| ChemIDplus related topics: | Naltrexone Naltrexone hydrochloride Nicotine polacrilex Nicotine tartrate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Naltrexone and Nicotine Replacement Effects on Cue Reactivity of Smokers |
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Adults who have smoked at least 25 cigarettes per day for at least a year. They are not using any method to quit smoking and are not using naltrexone. Must weigh at least 100lbs with no medical contraindications for naltrexone or transdermal nicotine. No contraindicated medications, no recent opiate use or history
Contacts and Locations More Information
| Study ID Numbers: | ADRD-020-97F |
| First Received: | July 3, 2001 |
| Last Updated: | September 4, 2007 |
| ClinicalTrials.gov Identifier: | NCT00018213 |
| Health Authority: | United States: Federal Government |
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